MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW, TI, 3.5 MM X 60 MM, STRL; BONE FIXATION PLATE

Model Number	LO-PRO SCRW, TI, 3.5 MM X 60 MM, STRL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an ankle fracture surgery the screw head broke off while the screw was inserted into the plate.The screw shaft remained in the patient.Other screws fixed the plate securely.The screw head was retrieved and discarded.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: LO-PRO SCRW, TI, 3.5 MM X 60 MM, STRL
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24335351
• Report Number: 1220246-2026-00580
• Device Sequence Number: 4812764
• Product Code: HRS
• UDI-Device Identifier: 00888867211117
• UDI-Public: (01)00888867211117(11)240716(17)290630(10)15288627
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K203294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LO-PRO SCRW, TI, 3.5 MM X 60 MM, STRL
• Device Catalogue Number: AR-8935-60S
• Device Lot Number: 15288627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown